Status:
ENROLLING_BY_INVITATION
Evaluating Long-term Safety of Efgartigimod Administered Intravenously and Efgartigimod PH20 Administered Subcutaneously in Children With Generalized Myasthenia Gravis
Lead Sponsor:
argenx
Conditions:
Generalized Myasthenia Gravis
gMG
Eligibility:
All Genders
2-18 years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this trial is to evaluate the long-term safety of efgartigimod IV and efgartigimod PH20 SC administered to participants with gMG in the antecedent studies, ARGX-113-2006 and ARGX-113-22...
Eligibility Criteria
Inclusion
- The participant completed ARGX-113-2006, defined as:
- The participant reached End of Trial in trial ARGX-113-2006 or End of Study in ARGX-113-2207 and agreed to participate in the ARGX-113-2008 trial.
- The participant qualifies for retreatment in trial ARGX-113-2006, but cannot complete a Treatment Period (TP) and the required Intertreatment Period (IP) visits within the ARGX-113-2006 trial's timeframe.
- Either the participant or the participant's legally authorized representative can understand the requirements of the trial and provide written informed consent/assent, and willingness and ability to comply with the trial protocol procedures.
- Contraceptive use for sexually active participants should be consistent with local regulations for those participating in clinical studies.
Exclusion
- Female adolescents of childbearing potential (FAOCBP): Pregnancy or lactation, or the participant intends to become pregnant during their participation in the study.
- Discontinued early from ARGX-113-2006 or ARGX-113-2207 treatment.
- Clinically significant uncontrolled chronic bacterial, viral, or fungal infection at study entry not sufficiently resolved in the investigator's opinion or known autoimmune disease or any medical condition that would interfere with an accurate assessment of clinical symptoms of gMG or put the participant at undue risk.
Key Trial Info
Start Date :
August 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2029
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT05374590
Start Date
August 18 2022
End Date
September 1 2029
Last Update
December 16 2025
Active Locations (15)
Enter a location and click search to find clinical trials sorted by distance.
1
Ann and Robert H Lurie Children's Hospital of Chicago - Main Hospital
Chicago, Illinois, United States, 60611
2
University of Virginia (UVA) Health - Developmental Pediatrics Clinic
Charlottesville, Virginia, United States, 22903
3
Universitair Ziekenhuis Antwerpen
Edegem, Belgium, 2650
4
UZ Gent
Ghent, Belgium, 9000